Description and Brand Names

US Brand Name

Xerese

Descriptions

Acyclovir and hydrocortisone topical combination is used to treat the symptoms of herpes simplex virus infection on the lips and around the mouth (cold sores). Although this medicine will not cure herpes simplex, it may help the sores to heal faster and relieve some of the pain and discomfort. Acyclovir is an antiviral agent (treats a virus) and hydrocortisone is a steroid (cortisone-like) medicine.

This medicine is available only with your doctor's prescription.

This product is available in the following dosage forms:

Cream

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acyclovir and hydrocortisone topical combination in children younger than 6 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of acyclovir and hydrocortisone topical combination have not been performed in the geriatric population, no geriatric-specific problems have been documented to date.

Pregnancy

Information about this acyclovir-and-hydrocortisone-topical-application-route

Pregnancy Category

Explanation

All Trimesters

B

Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Weak immune system—This medicine may not work properly in patients with this condition.

Proper Use

Use this medicine only as directed by your doctor to benefit your condition as much as possible. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only for cold sores on the lips and around the mouth. Do not get it in your eyes, inside your mouth or nose, or on the genital area. If the cream does get on these areas, rinse it off with water right away.

To help clear up your herpes infection, keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Do not miss any doses.

To use:

Wash your hands with soap and water before and after using the cream.

Clean and dry the affected area before applying the cream.

Apply a thin layer to the affected area that covers the cold sore.

Do not rub the cream into the cold sore. Rubbing may spread the virus to other areas around your mouth or make your cold sore worse.

Do not cover the cold sore or the area around the cold sore with a bandage.

Do not bathe, shower, or swim until 30 minutes after applying the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For topical dosage form (cream):

For cold sores:

Adults and children 6 years of age and older—Apply to the affected area 5 times per day for 5 days.

Children younger than 6 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions

It is very important that your doctor check your progress after you use this medicine to see if the medicine is working properly.

If your symptoms do not improve within 2 weeks, or if they become worse, check with your doctor.

Do not use cosmetics or other skin care products (eg, make-up, sun screen, lip balm) on the treated area.

Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Burning, itching, redness, rash, swelling, soreness, or tingling at the application site

change in skin color at the application site

dryness or flaking of the skin

flushing or redness of the skin

unusually warm skin

Incidence not known

Blistering, burning, or crusting of the skin

itching, scaling, severe redness, soreness, or swelling of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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